5470-SYN eBook-Nordlys_v2

NordlysTM The foundational platform for your practice eBook



Dear reader, On behalf of Candela, we would like to thank you for your interest in the Nordlys™ system. The Nordlys system enables you to meet the increasing demand for aesthetic and dermatological procedures with a single multiapplication platform, CE-marked for 20 indications1,2,3,4. Developed over 20 years and using three foundational technologies, Ellipse IPL™, Frax 1550, and Nd:YAG 1064, this device has the promise to become the cornerstone of your practice. In this eBook, we provide you with the most important information regarding this device, from technology overview to results clinical experts worldwide have achieved with their patients. Know that when you decide to work with one or more of our devices, we’ll do everything we can to provide you with the highest level of customer service possible. That’s our promise to you. The Candela Marketing Team 1. Nordlys system instructions for use, 2018. Candela, data on file. 3 2. Ellipse Nordlys CE Mark clearance. 3. Ellipse Nordlys 510(k) clearance (K161162), September 2016. 4. Wizer. Global market research, July 2017. Candela, data on file.

Science. Results. Trust. Science. What can you treat? One single, multi-application platform, 3 foundational technologies: Ellipse IPL™, Frax 1550 and ND:YAG 1064. 01 Photorejuvenation(a) 11 Venous lakes 20 02 Telangiectasias 12 Leg veins indications1,2,3 03 Rosacea 13 Acne scars 14 Surgical scars 04 Benign pigmented 15 Striae lesions 16 Skin resurfacing 17 Hair removal 05 Benign vascular lesions Poikiloderma of 06 Civatte 07 Port wine stains 08 Resistant PWS 18 Acne 09 Wrinkles 19 Warts 10 Skin texture 20 Onychomycosis a. Via vascular and pigmented lesion treatment 1. Ellipse Nordlys CE Mark. 2. Ellipse Nordlys 510(k) clearance (K161162), September 2016. 3. Port Wine Stain (PWS) Found to Be Resistant to Pulse Dye Laser (PDL), Long Pulse Dye Laser (LPDL) or IPL Treatment 4

Science. Results. Trust. Science. Patient advantages: Give your patients what they want: The assurance of proven results. With 20 years of clinical experience, the Nordlys system is one of the most proven multi- 01 application systems available in the market today. Comfort. SoftCool1 sends a focused stream of cool air for greater comfort during and after 02 the treatment. The device is quiet in operation, providing a relaxed environment for both operator and the person being treated. More treatment options. The state of the art treatment gives you the option of using either a 03 laser or light-based technology. Some people aren’t comfortable with a laser, so this makes things feel more relaxing. 04 Fewer treatments. The combination of lower fluence and narrowband results in fewer treatments2. 05 All-season treatment. The Nordlys system can be used on skin types I-VI, in any season and any climate. 1. SoftCool is only available with Frax 1550 and Nd:YAG1064 2. Bjerring P, et al. Lasers Surg Med. 2004;34(2):120-126 5

Science. Results. Trust. Science. Practice advantages: Meet the demand for the most desired treatments. The Nordlys system enables you to treat 20 different indications with 3 foundational technologies: Ellipse IPL, Frax 1550, and Nd:YAG 10641,2. Designed for ease of use. Guided mode, Expert mode, and optional Pulse Definition mode3 enable a short learning curve and expansion of versatility as the user becomes more adept. The intuitive user interface makes using the device easy. Scalable to grow with your practice. The system can be upgraded with additional applicators when needed. Reliability matters: The Nordlys system offers secure, Wi-Fi–enabled remote assistance and you can diagnose and update your device during or after working hours. Patient database available to allow you to build a patient record and review treatment history. Candela 360 Advantage support program to help your practice achieve measurable growth and consistent treatment outcomes while attaining unparalleled patient satisfaction. 1. Ellipse Nordlys CE Mark. 2. Ellipse Nordlys 510(k) clearance (K161162), September 2016. 3. ThePulse Definition mode is priced separately. 6

Science. Results. Trust. Science. Mechanism of action | Ellipse IPL Patented Ellipse IPL uses exclusive selective wavelength technology with dual filters to deliver narrowband IPL to the target tissue2, filtering out any potentially harmful wavelengths. • Uniquely delivers submilli- • 8 applicators, including second IPL pulses to treat PR 530 and VL 555 small vascular lesions and for vascular lesions diffuse redness1,2 and photorejuvenation treatments2 Enables truly customisable treatments: user can control.2 • Energy delivered • Time between sub-pulses • Pulse duration • Narrowband wavelengths • Number of pulses in a train used for treatment Ellipse IPL Ellipse IPL uses narrower wavelength bands, per condition, which enables treatment of photodamaged skin using less than half the fluence and no active cooling, and requiring fewer treatments than reported in studies with broadband IPL devices.3 IPL photorejuvenation with Ellipse IPL using relatively shorter wavelengths and pulse widths showed significant macroscopic and quantitative improvements, especially in the treatment of epidermal pigmentation and improvement of basic skin tone.4 7

Science. Results. Trust. Science. Mechanism of action | Frax 1550 Designed for non-ablative skin resurfacing and treatment of acne scars, scars, and striae.1 • Unique non-ablative • SoftCool sends a focused fractional technology uses a stream of cool air for greater software algorithm to set the comfort during and after the parameters. It enables the treatment user to set the pulse duration • No expensive consumables and the energy, independently with the Frax 1550 applicator • Control the thermal impact • Deliver the required density 2 important design features help Frax 1550 maintain treatment consistency: • Move the roller too slowly, and it will not fire a new row • Move the roller too quickly, and a warning light will be displayed The magnetically coupled roller detaches for easy cleaning. 8

Science. Results. Trust. Science. Mechanism of action | Nd:YAG 1064 Designed to treat benign vascular lesions such as1: • Leg veins • Onychomycosis • Venous lakes • Warts • Resistant port wine stains Patented, integrated SoftCool technology enables treatment Nd:YAG 1064 without the constriction of underlying vessels, which can occur with contact cooling. Software-controlled zoom enables easy change in spot sizes from 1.5-5.0 mm for treatment flexibility. Handpiece has 3 tips: • Circular2 for use when treating telangiectasia, reticular vessels, hemangiomas, and more • Semi-circular2 for use when treating difficult-to-reach vessels near the eye and onychomycosis treatments • Circular sapphire2 for use when light pressure is needed to isolate the vessel 1. Ellipse Nordlys CE Mark clearance. 2. Nordlys system instructions for use, 2018. Candela, data on file. 3. Bjerring P, Christiansen K, Troilius A, Dierickx C. Facial photo rejuvenation using two different intense pulsed light (IPL) wavelength bands. Lasers Surg Med. 2004;34(2):120-126. 4. Negishi K, Kushikata N, Takeuchi K, Tezuka Y, Wakamatsu S. Photorejuvenation by intense pulsed light with objective measurement of skin color in Japanese patients. Dermatol Surg. 2006;32(11):1380-1387. 9

Science. Results. Trust. Results Port Wine Stains | Ellipse IPL Before Post 3 Treatments Courtesy of Tomás Zamora, M.D., Spain Before Post 8 Treatments Courtesy of Prof. Michael Drosner, M.D., Germany Before Post 5 Treatments Courtesy of Plong Panh Chak Ritha, M.D., Thailand Photos are unretouched. Individual results may vary. 10

Science. Results. Trust. Results. Telangiectasias | Ellipse IPL Before Post 2 Treatments Courtesy of Prof. Peter Bjerring, M.D., Denmark Before Post 3 Treatments Courtesy of Guillermo Simón, M.D., Spain Before Post 3 Treatments Courtesy of Prof. Peter Bjerring, M.D., Denmark Photos are unretouched. Individual results may vary. 11

Science. Results. Trust. Results. Diffuse Redness | Ellipse IPL Before Post 3 Treatments Courtesy of Prof. Peter Bjerring, M.D., Denmark Before Post 2 Treatments Courtesy of Harue Suzuki, M.D., Japan Before Post 3 Treatments Courtesy of Prof. Peter Bjerring, M.D., Denmark Photos are unretouched. Individual results may vary. 12

Science. Results. Trust. Results. Rosacea | Ellipse IPL Before Post 1 Treatment Courtesy of Prof. Michael Drosner, M.D., Germany Before Post 3 Treatments Courtesy of Guillermo Simón, M.D., Spain Before Post 3 Treatments Courtesy of Prof. Agneta Troilius Rubin, M.D., Sweden Photos are unretouched. Individual results may vary. 13

Science. Results. Trust. Results. Photorejuvenation | Ellipse IPL Before Post 3 Treatments Courtesy of Guillermo Simón, M.D., Spain Before Post 1 Treatment Courtesy of Prof. Michael Drosner, M.D., Germany Before Post 2 Treatments Courtesy of Prof. Agneta Troilius Rubin, M.D., Sweden Photos are unretouched. Individual results may vary. 14

Science. Results. Trust. Results. Hair Removal | Ellipse IPL Before Post 4 Treatments Courtesy of Prof. Agneta Troilius Rubin, M.D., Sweden Before Post 3 Treatments Courtesy of Prof. Peter Bjerring, M.D., Denmark Before Post Treatment Courtesy of Jochmann Wolfgang, M.D., Austria Photos are unretouched. Individual results may vary. 15

Science. Results. Trust. Results. Acne | Ellipse IPL Before Post 1 Treatment Courtesy of Prof. Agneta Troilius Rubin, M.D., Sweden Before Post 3 Treatments Courtesy of Prof. Michael Drosner, M.D., Germany Before Post 5 Treatments Courtesy of Yuichi Sai, M.D., Japan Photos are unretouched. Individual results may vary. 16

Science. Results. Trust. Results. Venous Lake | Nd:YAG 1064 Before Post 1 Treatment Courtesy of Ellipse Denmark Periorbital Telangiectasia | Nd:YAG 1064 Before Post 1 Treatment Courtesy of Ellipse Denmark Leg Veins | Nd:YAG 1064 Before Post 1 Treatment Courtesy of Prof. Michael Drosner, M.D., Germany Photos are unretouched. Individual results may vary. 17

Science. Results. Trust. Results. Skin Resurfacing | Frax 1550 Before Post 2 Treatments Courtesy of E. Victor Ross, M.D., USA Before Post 2 Treatments Courtesy of Ioanna Panoutsopoulou, M.D., Greece Before Post 1 Treatment Courtesy of Vicent Alonso, M.D., Spain Photos are unretouched. Individual results may vary. 18

Science. Results. Trust. Trust. Summary of peer-reviewed articles | Ellipse IPL Facial photo rejuvenation using two different intense pulsed light (IPL) wavelength bands. Study design 35 subjects (33 females, 2 males) with mean age 46.6±9.5 years (range 33-72), Fitzpatrick Skin Types I-III, and substantial photodamaged skin (10 subjects with irregular pigmentation, 13 with vascular lesions, 12 with both). Results at 3-month follow-up after last treatment: • 82% of subjects showed fair to excellent (25-100%) clearance of telangiectasias with the PR applicator • 73% of subjects showed fair to excellent clearance of diffused erythema with the PR applicator • Combined VL and PR treatments required less than 1/2 the fluence, no active cooling, and fewer treatments than conventional treatment with a single set of treatment parameters Bjerring P, et al. Lasers Surg Med. 2004;34:120-126. 19

Science. Results. Trust. Trust. Summary of peer-reviewed articles | Ellipse IPL Photorejuvenation by intense pulsed light with objective measurement of skin colour in Japanese patients. Study design 25 Japanese women with a mean age of 50±9 years (range 31-68), Fitzpatrick Skin Types III-IV, and mild (n=16), moderate (n=6) or severe (n=3) photod­ amage. Results at 3-month follow-up after last treatment: • 96% of subjects showed Grade B or greater (50-100%) improvement of skin texture • 64% of subjects showed Grade B or greater (50-100%) improvement of pigmentation • High patient satisfaction (all patients reported “satisfied” to “extreme satisfaction”) Negishi K, et al. Dermatol Surg. 2006 Nov;32:1380-1387. 20

Science. Results. Trust. Trust. Summary of peer-reviewed articles | Ellipse IPL Treatment of facial acne papules and pustules in Korean patients using an intense pulsed light device equipped with a 530- to 750-nm filter. Study design 30 females (mean age 25.7 years, range 23-32; skin types III-IV) with mild to moderate acne, Grade 2 (Papules 11-30), according to Korean acne grading system. Results at 3-week follow-up after last treatment: • All subjects were satisfied with treatment • 63% of red macules showed good (50-75%) to excellent (>75%) improvement • 63% of irregular pigmentation and skin tone evaluations showed good (50-75%) to excellent (>75%) improvement Chang SE, et al. Dermatol Surg. 2007 Jun;33:676-679. 21

Science. Results. Trust. Trust. Summary of peer-reviewed articles | Frax 1550 Clinical evaluation and in-vivo analysis of the performance of a Fractional Infrared 1550 nm Laser System for skin rejuvenation. Study design 5 female subjects between the ages of 44 and 71 years, with visible wrinkles and/or dyspigmentation. Results at the 3-month follow-up after last treatment: • Mean improvement scores were: 1.6 for wrinkles, 1.8 for skin texture, and 1.7 for pigmentation (all statistically significant) • Treatments were well tolerated (mean pain score of 4.2 on a pain scale from 0 (no pain) to 10 (worst pain possible), and patients noted very little downtime Tidwell WJ. Journal of Cosmetic and Laser Therapy. 2018;20(6):360-363. 22

Science. Results. Trust. Trust. Don’t take our word. Take it from our customers. “The Nordlys system has been a great breakthrough in laser and light technology. Treatment with submillisecond pulses allows us to make more effective treatments in vascular and pigmentary pathology. Along with the new applicator Frax 1550, this makes a complete platform in solving medical and aesthetic dermatological problems. All this confirms the commitment of the development team to implement technological solutions always with the advice of dermatologists.” - Vicent Alonso, M.D. Cosmetic Dermatologist, Godelia, Spain “Nordlys is one of the best engineered systems on the market. Nordlys has further advanced their innovative Ellipse IPL with selective waveband technology and Nd:YAG platform to treat even more conditions effectively, quickly, and efficiently. The novel Frax 1550 laser device offers important improvements of aging facial skin with short downtime and minimal side effects.” - E. Victor Ross, M.D. Director of the Scripps Clinic Laser and Cosmetic Dermatology Center San Diego, USA

Science. Results. Trust. Trust. “Nordlys is the first IPL system to deliver a pulse as short as 0.5 ms. Using the Ellipse IPL selective waveband technology, only wavelengths that are beneficial to treatment of the target chromophores are used. Since wavelengths that mainly heat up tissue water are excluded, there is normally no need to protect the epidermis by surface cooling.” - Prof. Peter Bjerring, Dermatologist, Vejle, Denmark “As a physician who utilizes the Ellipse IPL platform and considers it a foundational technology for all dermatology practices, I am pleased that Candela can now offer the full spectrum of light, laser and energy- based solutions to physicians and patients worldwide.” - Jill Waibel, M.D, Board-Certified Dermatologist and Medical Director/Founder of Miami Dermatology and Laser Institute in Miami Florida, USA “The combination of IPL and Nd YAG 1064nm laser covers most of the dermatologic disorders that a general dermatologist would treat in day-to-day practice. This is why we selected the Nordlys and we are extremely happy with its performance, speed of operation and reliability.” - Brian De’Ambrosis, M.D. Dermatologist, Canna Heights Australia

System specifications Product Spseycsifitceamtion Innovative solutions for face and body 3 foundational technologies for your practice NORDLYS APPLICATOR SPECIFICATIONS NORDLYS PRODUCT SPECIFICATIONS FEATURES ELLIPSE IPL PR/PRS 530 (530-750 nm) PL 400 (400-720 nm) Technologies Ellipse IPL, Frax 1550, Type/Wavelength HRD 645 (645-950 nm) Nd:YAG 1064 Band HR/HRL 600 (600-950 nm) VL/VLS 555 (555-950 nm) Connectors 2 Touch Screen 10” Fluence Range 2-26 J/cm2 Remote Assistance Yes Accessories Tray Yes Pulse Time 0.5-99.5 ms (depending on applicator) Patient Database Yes Guided Treatment Yes: select treatment, skin Pulse Delay 1.5-99.55 ms type, suntan, hair thickness, Number of Pulses 1-4 vessel size User Modes Guided, Expert, and optional Duration of 0.5-700 ms Pulse Definition modes Pulse Train CONSOLE SPECIFICATIONS Spot Size HR 600, HRD HRL 600 VLS 555, PRS 530 645, VL 555, PR Dimensions 20” x 25.6” x 45” 530, PL 400 18 mm x 48 mm Hexagonal: 90 mm2 (D x W x H) (51 cm x 65 cm x 115 cm) 10 mm x 48 mm Weight 128 lbs (58 kg) Electrical Input Version I: 100-120 VAC FRAX 1550 ND:YAG 1064 Version II: 200-240 VAC Laser 1550 nm 1064 nm Frequency 50/60 Hz Wavelength Maximum Power Version I: 1300 VA Fluence Range/ 5-100 mJ 20-500 J/cm2 Consumption Version II: 2000 VA Energy 6-40 J/cm2 (onychomycosis) 0543 Pulse Duration 1-20 ms 2.5-90 ms 0.3-0.9 ms (onychomycosis) Scan Width/ 4-12 mm 1.5-5.0 mm Spot Sizes Skin Cooling SoftCool Integrated Air Cooling Aiming Beam 650 nm Cable 3.2 m with flexible joint for user comfort For more information about how the Nordlys system may help achieve your practice goals, contact your local Candela sales professional or visit syneron-candela.com. 1. Ellipse Nordlys CE Mark clearance. 2. Nordlys system instructions for use, 2018. Candela, data on file. 3. Simón G. Before and after photos. Candela, data on file. 4. Drosner M. Before and after photos. Candela, data on file. 5. Ellipse A/S. Before and after photos. Candela, data on file. 6. Rubin AT. Before and after photos. Candela, data on file. 7. Ross EV. Before and after photos. Candela, data on file. 8. Wizer. Global market research, July 2017. Candela, data on file. 9. Bjerring P, Christiansen K, Troilius A, Dierickx C. Facial photo rejuvenation using two different intense pulsed light (IPL) wavelength bands. Lasers Surg Med. 2004;34(2):120-126. 10. Negishi K, Kushikata N, Takeuchi K, Tezuka Y, Wakamatsu S. Photorejuvenation by intense pulsed light with objective measurement of skin color in Japanese patients. Dermatol Surg. 2006;32(11):1380-1387. 25 © 2019 Candela Corporation. This material contains registered trademarks, trade-names and brand names of Candela Corporation and its affiliates, including Syneron, Candela, Ellipse A/S, and Nordlys. All other trademarks are the property of their respective

www.candelamedical.com Disclaimer: All contents of this material are for informational purposes only and provided by Candela without warranties of any kind. Healthcare professionals are solely responsible for making their own independent evaluation as to the suitability of any product for any particular purpose and in accordance with country specific regulations. The availability of products and the indications mentioned in this material is subject to the regulatory requirements and product registration status in each country. Refer to the User Manual for country specific indications.  Products and technical specifications may change without notice.  Please contact Candela  for more details. © 2019 Candela Corporation. This material contains registered and unregistered trademarks, trade-names, service marks and brand names of Candela Corporation and its affiliates. All other trademarks are the property of their respective owners. All rights reserved. PU0700EN 26